Clinical trials: Postoperative Infection of Incision
Surgical Site Infection, Colon Surgery
D-PLEX 311: Safety and Efficacy of D-PLEX in the Prevention of Post Abdominal Surgery Incisional Infection
Phase III, Prospective, Multinational, Multicenter, Randomized, Controlled, Two-arm, Double Blind Study to assess Efficacy and Safety of D-PLEX Administered Concomitantly with the Standard of Care (SoC), compared to a SoC treated…
- Conditions
- Surgical Site Infection, Colon Surgery, Abdominal Surgery, Post-Op Infection
- Trial name
- NCT04233424
- Testing
- D-PLEX, Standard of Care (SoC)
- Where
- 62 sites in United States, Bulgaria and 8 more
- Volunteers
- 977 people
- Sponsor
- PolyPid Ltd.
Surgical Wound Infection
Effects of a New Antimicrobial Dressing on Wound Healing and Incidence of Sternal Wound Infections
The primary objective of this pivotal study is to determine if a new antimicrobial dressing, applied to the sternal incisions of cardiac surgical subjects, will demonstrate a decreased cumulative incidence rate(CI) of localized…
- Trial name
- NCT00203541
- Testing
- TELFA™ A.M.D. Island dressing
- Where
- United States
- Volunteers
- 1,100 people
- Sponsor
- Tyco Healthcare Group
Fractures, Open, Fractures, Closed
LOQTEQ® Antibacterial Pre-Market Study
aap001 is a randomized, controlled, subject-blinded, multi-center study to show the safety of the LOQTEQ® antibacterial silver-coated system is non-inferior in comparison with the uncoated LOQTEQ® system
- Conditions
- Fractures, Open, Fractures, Closed, Surgical Site Infection, Fracture of Fibula
- Trial name
- NCT05260463
- Testing
- Implantation
- Where
- 13 sites in Germany
- Volunteers
- 203 people
- Sponsor
- aap Implantate AG
Surgical Wound, Surgical Site Infection
Clinical Assessment of Next Science Wound Gels in Healing Below the Knee Amputation Surgical Wound Compared to SOC
This is a 64-patient, 90-day, open -label study on adult patients undergoing below knee amputation for various etiologies. The objective of this study is to assess surgical wound healing and wound bioburden using combination…
- Conditions
- Surgical Wound, Surgical Site Infection, Surgical Wound Infection, Amputation Stump; Infection
- Trial name
- NCT04053946
- Testing
- Next Science Wounds Gels
- Sponsor
- Next Science TM
Surgical Site Infection
DFA-02 in Patients Undergoing Colorectal Surgery
This is a randomized, double-blind, placebo controlled, safety, tolerability, and pharmacokinetic dose escalation Phase II study of DFA-02 in patients undergoing colorectal surgery to evaluate the safety, tolerability and…
- Trial name
- NCT01496352
- Testing
- DFA-02
- Where
- 5 sites in United States
- Volunteers
- 30 people
- Sponsor
- Dr. Reddy's Laboratories Limited
Staphylococcal Infections, Surgical Site Infection
Effect of Exeporfinium Chloride (XF-73) Gel on Nasal S.Aureus in Patients at Risk of Post-op Staphylococcal Infection
This study looks at the difference between XF-73 and placebo in reducing the carriage of a bacteria S. aureus in the nose before, during and after heart surgery.
- Trial name
- NCT03915470
- Testing
- XF-73
- Where
- 21 sites in United States, Georgia and 1 more
- Volunteers
- 124 people
- Sponsor
- Destiny Pharma Plc
Surgical Site Infection
Preoperative Skin Preparation Study to Evaluate the Antimicrobial Capabilities of Four Test Substances
Comparative study of antimicrobial effectiveness evaluation of of 26ml Project X, 10.5ml Project X, 5.1ml Project X and Prevantics Maxi swabstick following ASTM E1173 - Standard test method for evaluation of preoperative…
- Trial name
- NCT04218110
- Testing
- Isopropyl alcohol & Chlorhexidine Gluconate Antiseptic, Prevantics 3.15 % / 70 % Swabstick
- Where
- Romania
- Volunteers
- 329 people, healthy volunteers welcome
- Sponsor
- Professional Disposables International, Inc.
Surgical Site Infection
Betadine Versus Saline in Swapping of Subcutaneous Tissue
Caesarean section is an increasingly common major surgical procedure performed on women. Last decade an overall increase of the global rate of caesarean section, of up to 31.2%, was reported.
- Trial name
- NCT06595823
- Testing
- Betadine
- Where
- Egypt
- Volunteers
- 300 people
- Sponsor
- Egymedicalpedia
Infection, Surgical Site Infection
Efficacy and Safety of Ertapenem Sodium (MK-0826) Following Colorectal Surgery in Chinese Adults (MK-0826-056)
The purpose of this study is to evaluate the efficacy and safety of ertapenem sodium compared with ceftriaxone sodium/metronidazole for the prophylaxis of surgical site infection following elective colorectal surgery in Chinese…
- Trial name
- NCT01254344
- Testing
- ertapenem sodium, ceftriaxone sodium, metronidazole
- Volunteers
- 599 people
- Sponsor
- Merck Sharp & Dohme LLC
Hypothermia
Study to Determine the Effects of Pre-warming on OR Patient Temperatures and Surgical Outcomes
The application of active warming to patients whether awake or under general anesthesia has been proven safe in numerous studies and it is common practice to use warmers.
- Trial name
- NCT02177903
- Testing
- Bair Paws Patient Adjustable Warming System
- Where
- Canada
- Volunteers
- 220 people
- Sponsor
- Solventum US LLC
Postoperative Wound Infection-deep, Post Operative Wound Infection
A Phase I/II Double-Blind, Randomized, Controlled Study to Evaluate the Safety and Efficacy of RUT058-60
This is a double-blind, randomized, parallel-group, controlled, multi-center study to evaluate the safety and efficacy of RUT058-60 (Group A) as an intra-cavity lavage compared to sterile saline (Group B) in adult subjects…
- Trial name
- NCT02280395
- Testing
- RUT058-60, Sterile saline for irrigation
- Where
- 4 sites in United States
- Volunteers
- 9 people
- Sponsor
- Pulmatrix Inc.
Surgical Wound, Revision Total Knee Arthroplasty
Closed Incision Negative Pressure Therapy Versus Standard of Care Surgical Dressing in Revision Total Knee Arthroplasty
This study evaluates surgical site complications in subjects undergoing revision of a total knee arthroplasty when closed incision negative pressure therapy is used to manage the closed incision, as compared to a standard of care…
- Conditions
- Surgical Wound, Revision Total Knee Arthroplasty, Wounds and Injuries, Joint Disease
- Trial name
- PROMISES (NCT03274466)
- Testing
- Closed Incision Negative Pressure Therapy (ciNPT), Standard of Care Dressing
- Where
- 17 sites in United States
- Volunteers
- 294 people
- Sponsor
- KCI USA, Inc
Osteo Arthritis Shoulders
Air Barrier System for the Reduction of Airborne Colony-forming Units During Total Shoulder Arthroplasty
The objective of this study is to determine whether the Air Barrier System device reduces airborne colony-forming units (e.g., bacteria) present at a surgery site during total shoulder arthroplasty surgeries.
- Trial name
- NCT03782675
- Testing
- Control, Air Barrier System
- Volunteers
- 40 people
- Sponsor
- Nimbic Systems, LLC
Laparotomy, Incisional Hernia
Clinical Performance and Safety of Suture-TOOL
The goal of this single arm intervention study is to investigate the safety and performance of a suturing device for closure of the midline incision after open abdominal surgery.
- Conditions
- Laparotomy, Incisional Hernia, Wound Infection, Closure Technique
- Trial name
- NCT05695157
- Testing
- Suture-TOOL
- Where
- Sweden
- Volunteers
- 38 people
- Sponsor
- Suturion AB
Incisional Hernia After Midline Laparotomy, Colorectal Cancer
A One-year Follow-up of Incisional Hernia Formation Between Device Assisted and Manual Laparotomy Closure
The study compares one-year incisional hernia formation between two cohorts of patients that underwent open surgery for colorectal diseases.
- Trial name
- NCT07766044
- Testing
- Device assisted laparotomy closure, Manual laparotomy closure
- Where
- Sweden
- Volunteers
- 218 people
- Sponsor
- Suturion AB
Surgical Site Infection
Efficacy Study to Evaluate Antimicrobial Effectiveness of ZuraPrep™ (ZX-ZP-0055)
This is a randomized, paired-comparisons design where each subject receives two of the planned treatments.
- Trial name
- NCT02296645
- Testing
- ZuraPrep, ChloraPrep
- Where
- United States
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Zurex Pharma, Inc.
Surgical Site Occurences After Sternotomy, Wound Infection
The Use of PrevenaTM on Clean Closed Sternal Midline Incisions in Subjects at High Risk for Surgical Site Occurrences.
The purpose of this study is to compare the use of Prevena™ Incision Management System (IMS) versus standard wound care for the incision in subjects undergoing a sternal midline incision (sternotomy).
- Trial name
- NCT02195310
- Testing
- Prevena™ Incision Management System, Conventional sterile wound dressings
- Where
- 13 sites in Austria, Germany and 1 more
- Volunteers
- 342 people
- Sponsor
- Solventum US LLC
Abscess, Wound Infection
Single Dose vs. Two Dose Regimen of Dalbavancin for the Treatment of Acute Bacterial Skin and Skin Structure Infections
To compare the efficacy of treatment with a single dose of dalbavancin 1500 mg to treatment with a two dose regimen of dalbavancin (1000 mg on Day 1 followed by 500 mg on Day 8) in participants with known or suspected…
- Conditions
- Abscess, Wound Infection, Surgical Site Infection, Cellulitis
- Trial name
- NCT02127970
- Testing
- Dalbavancin
- Where
- 78 sites in United States, Bulgaria and 10 more
- Volunteers
- 698 people
- Sponsor
- Durata Therapeutics Inc., an affiliate of Allergan plc
Surgical Site Infection
Irrisept Versus Standard of Care in the Prevention of Surgical Site Infections
The purpose of this study was to compare the rate of surgical site infections in patients randomized to Irrisept versus SoC, who had an open abdominal laparotomy for abdominal trauma or acute surgical abdomen.
- Trial name
- NCT02255487
- Testing
- IrriSept System, No Intervention - Standard of Care (SoC) only
- Where
- 17 sites in United States
- Volunteers
- 627 people
- Sponsor
- Irrimax Corporation
Surgical Site Infections, Surgical Wound Infection
Light-Activated Antimicrobial Therapy to Prevent Surgical Site Infections
This is a Phase 3 multi-center, group-randomized, crossover trial to compare nasal antimicrobial photodisinfection therapy (aPDT) with standard of care for prevention of surgical site infections in patients undergoing major…
- Conditions
- Surgical Site Infections, Surgical Wound Infection, Infections, Anti-Infective Agents
- Trial name
- LANTERN (NCT06702878)
- Testing
- nasal antimicrobial photodisinfection therapy
- Where
- 14 sites in United States
- Volunteers
- 4,787 people
- Sponsor
- Ondine Biomedical Inc.